UCP RAPID DRUG SCREENING TESTS

Enzyme Immunoassay, Amphetamine

UCP BIOSCIENCES, INC.

The following data is part of a premarket notification filed by Ucp Biosciences, Inc. with the FDA for Ucp Rapid Drug Screening Tests.

Pre-market Notification Details

• Device ID: K050540
• 510k Number: K050540
• Device Name: UCP RAPID DRUG SCREENING TESTS
• Classification: Enzyme Immunoassay, Amphetamine
• Applicant: UCP BIOSCIENCES, INC. 1445 KOLL CIRCLE, STE. 111 San Jose, CA 95112
• Contact: Nancy Chen
• Correspondent: Nancy Chen; UCP BIOSCIENCES, INC. 1445 KOLL CIRCLE, STE. 111 San Jose, CA 95112
• Product Code: DKZ
• Subsequent Product Code: DIO
• Subsequent Product Code: DIS
• Subsequent Product Code: DJC
• Subsequent Product Code: DJG
• Subsequent Product Code: DJR
• Subsequent Product Code: JXM
• Subsequent Product Code: LCM
• Subsequent Product Code: LDJ
• CFR Regulation Number: 862.3100 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-03-02
• Decision Date: 2005-04-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20817038020009	K050540	000
20817038021228	K050540	000
20817038021235	K050540	000
20817038021242	K050540	000
20817038021259	K050540	000
20817038021433	K050540	000
20817038021440	K050540	000
20817038021488	K050540	000
20817038021495	K050540	000
20817038021501	K050540	000
20817038020870	K050540	000
20817038020474	K050540	000
20817038020467	K050540	000
20817038020023	K050540	000
20817038020382	K050540	000
20817038020399	K050540	000
20817038020405	K050540	000
20817038020412	K050540	000
20817038020429	K050540	000
20817038020436	K050540	000
20817038020443	K050540	000
20817038020450	K050540	000
20817038021518	K050540	000
20817038021525	K050540	000
20817038021532	K050540	000
20817038021143	K050540	000
20817038021150	K050540	000
20817038021167	K050540	000
20817038021198	K050540	000
20817038021426	K050540	000
20817038021457	K050540	000
20817038021471	K050540	000
20817038021785	K050540	000
10850721007027	K050540	000
20817038020504	K050540	000
20817038020498	K050540	000
20817038020481	K050540	000
20817038021549	K050540	000
20817038021556	K050540	000
20817038021563	K050540	000
20817038021570	K050540	000
20817038021709	K050540	000
20817038021914	K050540	000
20817038021983	K050540	000
20817038021990	K050540	000
20817038022003	K050540	000
20817038022034	K050540	000